Quality Engineer II

Insight Global - Murrysville, PA

Full-time - Mid Level

Murrysville, PA

Administrative and Support Services

About the position

The Quality Engineer II role at Insight Global involves facilitating Corrective and Preventive Action (CAPA) investigations in the medical device industry. The position requires leading cross-functional teams, analyzing quality data, and ensuring compliance with regulatory standards. The engineer will work closely with management to support CAPA action plans and monitor their effectiveness.

Responsibilities

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.

Requirements

• Bachelor's degree plus a minimum of 5 years in the medical device or another regulated industry as a quality engineer or related.
• Understanding and application of global medical device regulations such as FDA's 21 CFR 820, ISO 13485, and others.
• Experience in Quality Management System processes, including cross sector or business process standardization.
• Ability to communicate and educate Quality Management System regulations, policies, and strategies to teams at all levels.
• Experience in corrective and preventive actions, including root cause analysis and documenting findings/actions.
• Advanced analytical skills with the ability to troubleshoot complex process/system issues.
• Experience working in Consent Decree situations or FDA Warning Letters.
• Experience using QMS software such as SAP.

Nice-to-haves

• Master's degree
• Experience conducting clinical trials or other research studies related to medical devices.